6 unchanged sentences
The parties moved to consolidate the two complaints on July 22, 2022, which were ordered consolidated on August 5, 2022.
−Removed: Memon and stockholder Nabil Saad filed motions for appointment of lead plaintiff/lead counsel on July 25, 2022.
−Removed: Saad withdrew his opposition on August 15, 2022, and Mr.
−Removed: Memon was appointed lead plaintiff on September 19, 2022.
−Removed: The complaint purports to be brought on behalf of stockholders who purchased our common stock from May 6, 2021 through May 2, 2022 (Mr.
−Removed: Memon’s complaint alleged a six-month longer class period than the complaint originally filed by Mr.
−Removed: The complaint generally alleges that we and certain of our officers violated Sections 10(b) and/or 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the New Drug Application for tebipenem HBr in an effort to lead investors to believe that the drug would receive approval from the FDA.
−Removed: The complaint seeks unspecified damages, interest, attorneys’
+Added: The parties filed an Amended Complaint on December 5, 2022, purported to be brought on behalf of stockholders who purchased our common stock from September 8, 2020 through May 2, 2022.
+Added: The Amended Complaint generally alleges that we and certain of our officers violated Sections 10(b) and/or 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the New Drug Application (“NDA”) for tebipenem HBr in an effort to lead investors to believe that the drug would receive approval from the FDA.
+Added: Plaintiffs seek unspecified damages, interest, attorneys’
fees, and other costs.
−Removed: Memon filed an amended complaint on December 5, 2022.
−Removed: The amended complaint generally restates the same
−Removed: allegations contained in the original complaint.
−Removed: The Court held a pre-motion conference on February 22, 2023 and set a date of June 21, 2023 for us to file our fully-briefed motion to dismiss, including Plaintiffs’
−Removed: opposition, which we filed within that deadline.
−Removed: We deny any allegations of wrongdoing and intend to vigorously defend against this lawsuit.
+Added: We filed a fully-briefed Motion to Dismiss on June 21, 2023.
+Added: The Court has not yet ruled on the Motion.
+Added: A shareholder derivative action was filed against us, as nominal defendant, and certain of our officers in the United States District Court for the District of Delaware, captioned Marti v.
+Added: Mahadevia, et al., Case.
+Added: 1:23-cv-01133-RGA (the “Derivative Complaint”), on October 11, 2023.
+Added: The plaintiffs both purport to be current stockholders, and the allegations are primarily the same as those made in the putative class action.
+Added: We deny any allegations of wrongdoing and intend to vigorously defend against these lawsuits.
However, there is no assurance that we will be successful in our defense or that insurance will be available or adequate to fund any settlement or judgment or the litigation costs of this action.
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We may not commercialize, market, promote or sell any product candidate in the United States without obtaining marketing approval from the FDA or in other countries without obtaining approvals from comparable foreign regulatory authorities, such as the EMA, and we may never receive such approvals.
−Removed: We must complete extensive preclinical development and clinical trials to demonstrate the safety and efficacy of our product candidates in humans before we will be able to obtain these approvals.
+Added: We must complete extensive preclinical development and clinical trials to
+Added: demonstrate the safety and efficacy of our product candidates in humans before we will be able to obtain these approvals.
Clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome.
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It is possible that even if one or more of our product candidates has a beneficial effect, that effect will not be detected during clinical evaluation as a result of one of the factors listed or otherwise.
−Removed: Conversely, as a result of the same factors,
−Removed: our clinical trials may indicate an apparent positive effect of a product candidate that is greater than the actual positive effect, if any.
+Added: Conversely, as a result of the same factors, our clinical trials may indicate an apparent positive effect of a product candidate that is greater than the actual positive effect, if any.
Similarly, in our clinical trials, we may fail to detect toxicity of or intolerability of our product candidates or may determine that our product candidates are toxic or not well tolerated when that is not in fact the case.
53 unchanged sentences
Analyses of preliminary or interim data from our clinical studies are not necessarily predictive of analyses of final data.
−Removed: Analyses of preliminary and interim data are subject to the risk that one or more of the clinical outcomes may materially change, as
−Removed: more patient data become available and we issue our final clinical study report.
+Added: Analyses of preliminary and interim data are subject to the risk that one or more of the clinical outcomes may materially change, as more patient data become available and we issue our final clinical study report.
Preliminary or interim data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published.
104 unchanged sentences
If we are forced to lower the price we charge for our product candidates, if approved, our gross margins may decrease, which would adversely affect our ability to invest in and grow our business.
−Removed: To the extent any of our product candidates we develop are used in an outpatient setting, the commercial success of our product candidates will depend substantially, both domestically and abroad, on the extent to which coverage and reimbursement for these products and related treatments are available from government health programs and third-party payors.
+Added: To the extent any of our product candidates we develop are used in an outpatient setting, the commercial success of our product candidates will depend substantially, both domestically and abroad, on the extent to which coverage and reimbursement for these
+Added: products and related treatments are available from government health programs and third-party payors.
If coverage is not available, or reimbursement is limited, we may not be able to successfully commercialize our product candidates.
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Such a loss could also expose us to regulatory enforcement, civil liability and reputational damage.
−Removed: To the extent that any disruption or security breach results in a loss of or damage to our data or applications, or
−Removed: inappropriate disclosure or theft of confidential or proprietary information, in addition to incurring liability, the further development of our product candidates could be delayed or our competitive position could be compromised.
+Added: To the extent that any disruption or security breach results in a loss of or damage to our data or applications, or inappropriate disclosure or theft of confidential or proprietary information, in addition to incurring liability, the further development of our product candidates could be delayed or our competitive position could be compromised.
Any such disruption or security breach, as well as any action by us or our employees or contractors that might be inconsistent with the rapidly evolving data privacy and security laws and regulations applicable within the United States and elsewhere where we conduct business, could result in enforcement actions by the United States, the United States Federal government or foreign governments, liability or sanctions under data privacy laws that protect personally identifiable information, regulatory penalties, other legal proceedings such as but not limited to private litigation, the incurrence of significant remediation costs, disruptions to our development programs, business operations and collaborations, diversion of management efforts and damage to our reputation, which could harm our business and operations.
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CPRA imposes additional obligations on companies covered by the legislation and will expand consumers’
−Removed: rights with respect to certain sensitive personal information CPRA also creates a new state agency that will be vested with the authority to implement and enforce CCPA and CPRA.
+Added: rights with respect to certain sensitive personal information CPRA also creates a new state agency that will be vested with the authority to
+Added: implement and enforce CCPA and CPRA.
CCPA has prompted a number of proposals for new federal and state privacy legislation that, if passed, could increase our potential liability, increase our compliance costs and adversely affect our business.
3 unchanged sentences
Natural disasters could severely disrupt our operations and have a material adverse effect on our business operations.
−Removed: If a natural disaster, health epidemic, such as COVID-19, or other events beyond our control occurred that prevented us from using all or a significant portion of our office, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it may be difficult for us to continue our business for a substantial period of time.
−Removed: The COVID-19 pandemic has and could continue to adversely impact our business, including our preclinical studies and clinical trials.
−Removed: In March 2020, the World Health Organization declared the global outbreak of COVID-19 to be a pandemic.
−Removed: We continue to closely monitor the recent COVID-19 developments, including the lifting of COVID-19 safety measures, the drop in COVID-19 vaccination rates, the implementation of, and reaction to, vaccine mandates, the spread of new strains or variants of the coronavirus, and supply chain and labor shortages.
−Removed: The COVID-19 pandemic has had, and is expected to continue to have, an adverse impact on our operations.
−Removed: As a result of the COVID-19 pandemic or similar pandemics, we have experienced, and may in the future experience, certain disruptions that could materially impact our business, preclinical studies and clinical trials.
−Removed: We are continuing to monitor and assess the effects of the COVID-19 pandemic on our operations.
−Removed: However, we cannot at this time accurately predict what effects these conditions will ultimately have on our business, operations, preclinical studies and clinical trials due to uncertainties relating to variants, the severity of the disease, the duration of the outbreak, and the length of the travel restrictions and business closures imposed by the governments of impacted countries.
−Removed: In addition, the COVID-19 pandemic could continue to adversely affect the economies and financial markets of many countries, which could result in an economic downturn that could affect demand for our products and likely impact our operating results.
+Added: If a natural disaster, health epidemic, such as the coronavirus ("COVID-19"), or other events beyond our control occurred that prevented us from using all or a significant portion of our office, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it may be difficult for us to continue our business for a substantial period of time.
Risks Related to Our Financial Position and Need for Additional Capital
2 unchanged sentences
We have not generated any revenue from the sale of our products and have incurred losses in each year since our inception in 2013.
−Removed: Our net losses were $11.9 million and $25.2 million during the three and six months ended June 30, 2023, respectively.
+Added: Our net losses were $3.2 million and $28.4 million during the three and nine months ended September 30, 2023, respectively.
All of our product candidates are in development, none have been approved for sale and we may never have a product candidate approved for commercialization.
1 unchanged sentence
We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the issuance of the financial statements included in this report.
−Removed: Based on our cash and cash equivalents as of June 30, 2023, and inclusive of the $30.0 million development milestone payment to be received from GSK, as described under “Recent Developments”
−Removed: above, we believe that our cash runway will be sufficient to fund us into the second half of 2025.
+Added: Based on our cash and cash equivalents as of September 30, 2023, we believe that our cash runway will be sufficient to fund us into the second half of 2025.
Beyond this point we will need additional funding, which primarily consist of raising additional capital through some combination of equity or debt financings, potential new collaborations or partnerships, additional grant funding and/or reducing cash expenditures.
14 unchanged sentences
Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.
−Removed: Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’
+Added: Our prior losses, combined with
+Added: expected future losses, have had and will continue to have an adverse effect on our stockholders’
equity and working capital.
12 unchanged sentences
We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the issuance of the financial statements included in this report.
−Removed: Based on our cash and cash equivalents as of June 30, 2023, and inclusive of the $30.0 million development milestone payment to be received from GSK as described under “Recent Developments”
−Removed: above, we believe that our cash runway will be sufficient to fund us into the second half of 2025.
+Added: Based on our cash and cash equivalents as of September 30, 2023, we believe that our cash runway will be sufficient to fund us into the second half of 2025.
Our cash forecasts are based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.
12 unchanged sentences
the extent to which we in-license or acquire other products and technologies.
−Removed: As of June 30, 2023, our non-dilutive sources of funding consisted of an award from BARDA for tebipenem HBr and an award from NIAID for SPR206.
+Added: As of September 30, 2023, our non-dilutive sources of funding consisted of an award from BARDA for tebipenem HBr and an award from NIAID for SPR206.
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
12 unchanged sentences
As of December 31, 2022, we had United States federal, state and foreign net operating loss carryforwards ("NOLs") of $291.9 million, $282.9 million and $4.6 million, respectively.
−Removed: The federal NOLs of $73.0 million will expire at various dates from 2033 to 2037 and approximately $218.9 million can be carried forward indefinitely.
+Added: Federal NOLs of $73.0 million will expire at various dates from 2033 to 2037 and approximately $218.9 million can be carried forward indefinitely.
The state NOLs begin to expire in 2033 and will expire at various dates through 2039.
21 unchanged sentences
We and certain of our executive officers have been named as defendants in two initiated lawsuits, which were ordered consolidated, that could result in substantial costs and divert management’s attention.
−Removed: We, and certain of our executive officers, were named as defendants in two purported class action lawsuits that generally allege that we and certain of our officers violated Sections 10(b) and/or 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the New Drug Application for tebipenem HBr in an effort to lead investors to believe that the drug would receive approval from the FDA.
+Added: We, and certain of our executive officers, were named as defendants in two purported class action lawsuits that generally allege that we and certain of our officers violated Sections 10(b) and/or 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the NDA for tebipenem HBr in an effort to lead investors to believe that the drug would receive approval from the FDA.
The parties moved to consolidate the two complaints on July 22, 2022, which were ordered consolidated on August 5, 2022.
−Removed: Both Kashif Memon and stockholder Nabil Saad filed motions for appointment of lead plaintiff/lead counsel on July 25, 2022.
−Removed: Saad withdrew his opposition on August 15, 2022, and Mr.
−Removed: Memon was appointed lead plaintiff on September 19, 2022.
−Removed: The complaint seeks unspecified damages, interest, attorneys’
+Added: The parties filed an Amended Complaint on December 5, 2022, purported to be brought on behalf of stockholders who purchased our common stock from September 8, 2020 through May 2, 2022.
+Added: The Amended Complaint generally alleges that we and certain of our officers violated Sections 10(b) and/or 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the NDA for tebipenem HBr in an effort to lead investors to believe that the drug would receive approval from the FDA.
+Added: Plaintiffs seek unspecified damages, interest, attorneys’
fees, and other costs.
−Removed: Memon filed an amended complaint on December 5, 2022.
−Removed: The amended complaint generally restates the same allegations contained in the original complaint.
−Removed: The Court held a pre-motion conference on February 22, 2023 and set a date of June 21, 2023 for us to file our fully-briefed motion to dismiss, including Plaintiffs’
−Removed: opposition, which we filed within that deadline.
+Added: We filed a fully-briefed Motion to Dismiss on June 21, 2023.
+Added: The Court has not yet ruled on the Motion.
We intend to engage in a vigorous defense of the lawsuit.
115 unchanged sentences
If we fail to comply with our obligations in the agreements under which we in-license or acquire development or commercialization rights to products, technology or data from third parties, we could lose such rights that are important to our business.
−Removed: We are a party to agreements with Meiji and GSK for tebipenem HBr, Vertex Pharmaceuticals for SPR720 and Everest Medicines and PBB Distributions Limited for SPR206, and we may enter into additional agreements, including license agreements, with other parties in the future that impose diligence, development and commercialization timelines, milestone payments, royalties, insurance and other obligations on us.
+Added: We are a party to agreements with Meiji and GSK for tebipenem HBr, Vertex Pharmaceuticals for SPR720 and Pfizer, Everest and PBB Distributions Limited for SPR206, and we may enter into additional agreements, including license agreements, with other parties in the future that impose diligence, development and commercialization timelines, milestone payments, royalties, insurance and other obligations on us.
For example, we have the Meiji License that gives us rights outside of the Meiji Territory to develop, manufacture, and commercialize tebipenem HBr as well as the right to use, cross-reference, file or incorporate by reference any information and relevant Meiji regulatory documentation to support any regulatory filings outside of the Meiji Territory.
3 unchanged sentences
In addition, pursuant to our GSK License Agreement, we granted GSK an exclusive royalty-bearing license, with the right to grant sublicenses, under our intellectual property and regulatory documents and a sublicense under certain intellectual property of Meiji and Meiji’s regulatory documents to develop, manufacture and commercialize the GSK Licensed Products in the GSK Territory.
−Removed: Under the terms of the GSK License Agreement, we received an upfront payment of $66.0 million for GSK to secure rights to the medicine and are entitled to invoice for a $30.0 million milestone upon achievement of a development milestone in July 2023.
+Added: Under the terms of the GSK License Agreement, we received an upfront payment of $66.0 million for GSK to secure rights to the medicine and received a $30.0 million milestone payment upon achievement of a development milestone in the third quarter of 2023.
Remaining potential payments are milestone based, and are (i) approximately $120.0 million in payments for the achievement of development milestones, (ii) up to $150.0 million in commercial milestone payments, (iii) up to $225.0 million in sales milestone payments, and (iv) tiered low single-digit to low double-digit royalties (if sales exceed $1.0 billion) tiered on net sales of GSK Licensed Products in the GSK Territory.
95 unchanged sentences
Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.
−Removed: Our competitors may seek to market generic versions of any approved products by submitting Abbreviated New Drug Applications to the FDA in which they claim that patents owned or licensed by us are invalid, unenforceable and/or not infringed.
+Added: Our competitors may seek to market generic versions of any approved products by submitting Abbreviated New Drug Applications (“ANDAs”) to the FDA in which they claim that patents owned or licensed by us are invalid, unenforceable and/or not infringed.
Alternatively, our competitors may seek approval to market their own products similar to or otherwise competitive with our products.
149 unchanged sentences
Even if we are successful in achieving regulatory approval to commercialize a product candidate, it may face competition from generic products earlier or more aggressively than anticipated, depending upon how well our future products perform in the United States prescription drug market.
−Removed: In addition to creating the 505(b)(2) NDA pathway, the Hatch-Waxman Amendments to the FDCA authorized the FDA to approve generic drugs that are the same as drugs previously approved for marketing under the NDA provisions of the statute pursuant to abbreviated new drug applications ("ANDAs").
+Added: In addition to creating the 505(b)(2) NDA pathway, the Hatch-Waxman Amendments to the FDCA authorized the FDA to approve generic drugs that are the same as drugs previously approved for marketing under the NDA provisions of the statute pursuant to ANDAs.
An ANDA relies on the preclinical and clinical testing conducted for a previously approved reference listed drug ("RLD"), and must demonstrate to the FDA that the generic drug product is identical to the RLD with respect to the active ingredients, the route of administration, the dosage form, and the strength of the drug and also that it is “bioequivalent”
140 unchanged sentences
Although we have formal employment agreements with our executive officers, these agreements do not prevent them from terminating their employment with us at any time.
−Removed: On May 3, 2022, we implemented a restructuring that reduced our workforce from 146 full-time employees as of December 31, 2021 to 41 full-time employees as of the end of the second quarter of 2022 following the restructuring.
−Removed: Pursuant to the restructuring and effective as of July 2, 2022, Cristina Larkin separated from us as our Chief Operating Officer and David Melnick, M.D.
−Removed: separated from us as our Chief Medical Officer.
−Removed: While we have confidence in our remaining leadership team, including the board of directors, the restructuring may cause concerns from third parties with whom we do business and may increase the likelihood of turnover of other key officers and employees.
If we lose one or more of our other executive officers or key employees, our ability to implement our business strategy successfully could be seriously harmed.
5 unchanged sentences
If we are unable to continue to attract and retain high quality personnel, our ability to develop and commercialize product candidates will be limited.
−Removed: We have undertaken internal restructuring activities that could result in disruptions to our business or otherwise materially harm our results of operations or financial condition.
−Removed: There can be no assurance that our restructuring will achieve the cost-savings, operating efficiencies or other benefits that we may initially expect.
−Removed: Restructuring activities may also result in a loss of continuity, accumulated knowledge and inefficiency during transitional periods and thereafter.
−Removed: In addition, internal restructurings can require a significant amount of time and focus from management and other employees, which may divert attention from operations.
−Removed: Further, our restructuring may result in unexpected expenses or liabilities and/or write-offs.
−Removed: If our restructuring fail to achieve some or all of the expected benefits therefrom, our cash resources may not last as long as estimated and our business, results of operations and financial condition could be materially and adversely affected.
If foreign approvals are obtained, we will be subject to additional risks in conducting business in international markets.
43 unchanged sentences
The closing bid price for our common stock must remain at or above $1.00 per share to comply with the Bid Price Requirement for continued listing.
−Removed: On August 8, 2022 we received a deficiency letter (the “Notice”) from the Listing Qualifications Department of the Nasdaq Stock Market, LLC (“Nasdaq”) notifying us that, for the preceding 30 consecutive trading
−Removed: days, the closing bid price of our common stock was below the Bid Price Requirement.
+Added: On August 8, 2022 we received a deficiency letter (the “Notice”) from the Listing Qualifications Department of the Nasdaq Stock Market, LLC (“Nasdaq”) notifying us that, for the preceding 30 consecutive trading days, the closing bid price of our common stock was below the Bid Price Requirement.
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we had until February 6, 2023 to regain compliance with the Bid Price Requirement.
12 unchanged sentences
If one or more of the analysts covering our business downgrade our stock or change their opinion of our stock, our share price would likely decline.
−Removed: In addition, if one or more of these analysts cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which could cause our share price or trading volume to decline.
+Added: addition, if one or more of these analysts cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which could cause our share price or trading volume to decline.
We can issue and have issued shares of preferred stock, which may adversely affect the rights of holders of our common stock.
7 unchanged sentences
otherwise adversely affect the market price or our common stock.
−Removed: We have in the past issued, and we may at any time in the future issue, shares of preferred stock.
−Removed: In connection with our July 2018 public offering, we issued 2,220 shares of our Series A Convertible Preferred Stock (“Series A Preferred Stock”) to certain affiliates of Biotechnology Value Fund, L.P.
−Removed: (“BVF”), each share of which was convertible into 1,000 shares of our common stock, subject to certain ownership restrictions.
−Removed: In November 2018, we entered into an exchange agreement with BVF to exchange 1,000,000 shares of our common stock previously held by BVF for 1,000 shares of our Series B Convertible Preferred Stock (“Series B Preferred Stock”), each share of which was convertible into 1,000 shares of our common stock, subject to certain ownership restrictions.
−Removed: In connection with our rights offering, which we launched in February 2020 and closed in early March 2020, we issued 2,287 shares of our Series C Convertible Preferred Stock (“Series C Preferred Stock”) to BVF, each share of which was convertible into 1,000 shares of our common stock, subject to certain ownership restrictions.
−Removed: In September 2020, in connection with our underwritten public offering, we issued 3,215,000 shares of our Series D Convertible Preferred Stock (“Series D Preferred Stock”) to BVF, each share of which was convertible on a one-to-one basis into shares of our common stock, subject to certain ownership restrictions.
−Removed: As of June 30, 2023, all of the Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, and Series D Preferred stock has been converted into shares of our common stock.
−Removed: If any other future holders of our shares of preferred stock convert their shares into common stock, existing holders of our common stock will experience dilution.
+Added: As of September 30, 2023, all of our previously issued Series A Convertible Preferred Stock, Series B Convertible Preferred Stock, Series C Convertible Preferred Stock, and Series D Convertible Preferred stock has been converted into shares of our common stock.
+Added: If any future holders of our shares of preferred stock convert their shares into common stock, existing holders of our common stock will experience dilution.
We have broad discretion in the use of our cash reserves and may not use them effectively.
66 unchanged sentences
Litigation is usually expensive and diverts management’s attention and resources, which could adversely affect our business and cash resources and our ability to execute on our partnership with GSK to eventually commercialize tebipenem HBr, or the ultimate value our stockholders receive in such partnership or other opportunity.
−Removed: Unregistered Sales of Equity Securities and Use of Proceeds.
+Added: Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities.
Defaults Upon Senior Securities.
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.